Immunoassay Market Size, Share & Trends Analysis Report By Product (Reagent & Kits, Analyzers/Instruments, Software & Services), By Technology (RIA, ELISA, Rapid Test), By Application, By End Use, By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global immunoassay market size was valued at USD 21.4 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 6.7% from 2021 to 2028. This growth can be attributed to the increase in chronic and infectious diseases, including the outbreak of COVID-19. In addition, the rise in the geriatric population, which is more prone to chronic and infectious diseases, will aid growth. An increase in the prevalence of chronic conditions, such as cancer, infections, cardiovascular diseases, autoimmune diseases, diabetes mellitus, and nephrological diseases, has led to wide usage of immunoassay techniques in disease diagnostics. The incidence of cancer is increasing steadily, which is expected to drive the demand for effective diagnostic methods such as immunoassay. This technique is significant in the determination of oncogenesis and diagnosis of cancer, such as benign or malignant, and its different stages. It facilitates the use of monoclonal and polyclonal antibodies to detect specific antigens in tissues by determining the presence of tumor antigens.

Applications of immunoassay-based diagnostics are significantly increasing globally. Public awareness campaigns aimed at identifying the symptoms of infectious diseases and ways to prevent them play an important role in controlling the disease epidemic. Thus, increased patient awareness has led to high demand for immunoassays. For instance, the advocacy program by the International Society for Infectious Diseases focuses on collaborating with clinicians, public health practitioners, and researchers globally and supporting the exchange of scientific knowledge and application of public health practices and evidence-based medicine. In addition, in 2018, the World Hepatitis Alliance launched the “Find the Missing Millions” campaign to raise awareness about hepatitis and remove barriers in clinical diagnostic settings.

Clinical interpretation of diagnostic tests is dependent on assay analyzers and the presence of a technical and skilled workforce. Results of assays are affected by the time taken for interpretation. Thus, technological advancements have led to an increase in the number of automated instruments and equipment used in laboratories. Automation has benefits such as higher efficiency and usage of less space and labor in laboratories. Thus, the market is witnessing lucrative growth as some market players are introducing automated laboratory systems and point-of-care compact, portable assay tests.

The use of antibodies in immunoassays is based on immune responses to the antigen of a particular microorganism. On the other hand, in molecular diagnostics, nucleic acid probes are based on specific genetic makeup. Thus, the adoption of molecular diagnostic tests is expected to increase over the forecast period, which may restrain the growth of the market for immunoassay.

Product Insights

In 2020, the reagents and kits segment dominated the market for immunoassay and accounted for the largest revenue share of 65.9%. The segment is expected to maintain its dominance over the forecast period. The large share can be attributed to the high demand for immunoassay reagents and kits for diagnosis purposes with the growing prevalence of infectious and autoimmune diseases. In addition, the approval and launch of novel immunoassay kits are expected to support segment growth.

On the other hand, the software and services segment is anticipated to witness a CAGR of 6.5% over the forecast period. This can be attributed to the increased availability and high demand for cost-effective immunoassay services in developing markets. For instance, in June 2020, Sysmex Corporation began providing novel coronavirus (SARS-CoV-2) antibody lab assay services.

Technology Insights

The EIA/ELISA segment dominated the market for immunoassay and held the largest revenue share of 63.7% in 2020. Some of the major advantages of this method over Immunoelectrophoresis and immunodiffusion are reduced assay time, quantitative results, and requirement of limited antisera for analysis.

Rapid test, also known as lateral flow immunoassay, is used to detect the existence of target analyte without utilizing specialized equipment. Rapid test technique has various applications such as in dengue and infections caused by Legionella, Salmonella, Campylobacter, Zika, and Listeria. Furthermore, monoclonal antibodies are used specifically for Immunoglobulin G (IgG), Immunoglobulin M (IgM), Immunoglobulin A (IgA), and Immunoglobulin (IgD) for precise identification of target analyte.

Application Insights

The infectious disease testing segment dominated the immunoassay market and held the largest revenue share of 28.3% in 2020. The segment is anticipated to hold its dominance over the forecast period. This high share can be attributed to the rise in the incidence of infectious diseases such as HIV, malaria, influenza, and the novel COVID-19. The launch of new products in the field of infectious disease testing is further driving the market growth.

The increasing prevalence of cancer cases globally is one of the major factors contributing to the growth of the market for immunoassay during the forecast period. According to a report published by International Agency for Research on Cancer, the incidence of cancer was estimated to be 18.1 million new cases, whereas about 9.6 million deaths due to the disease were recorded during 2018. Thus, a rise in the incidence of cancer is anticipated to boost the adoption of immunoassay.

End-use Insights

The hospital segment dominated the market for immunoassay and accounted for the largest revenue share of 32.9% in 2020. The rise in the number of hospitals has led to the high growth of this segment. With ongoing changes in the healthcare industry, the need for hospitals with advanced facilities has increased.

Blood banks are anticipated to exhibit the highest growth during the forecast period owing to the rising number of infectious diseases being tested for in these laboratories during the screening and processing of donated blood. Also, ELISA is simple to perform and requires minimal specialized instruments and equipment, hence, is widely used in blood banks.

Regional Insights

North America held the largest market share among all the regions in 2020 with a 41.5% share and is anticipated to dominate the market throughout the study period. This dominance can be attributed to the rising demand for diagnostics due to the increase in the incidence of cancer and the easy availability of technologically advanced diagnostic techniques. In addition, the high incidence of infectious diseases in the region, such as HIV, tuberculosis, and influenza, is boosting the demand for detection and treatment.

Asia Pacific is the fastest-growing market owing to the presence of a large geriatric population and high prevalence of infectious diseases in this region. In addition, the growing adoption of innovative laboratory techniques and procedures for faster investigation and diagnosis of infectious and chronic disorders is one of the factors driving the market in the region. Moreover, the introduction of molecular kits and the increase in demand for reagents used in diagnosis are also among the factors driving growth.

Key Companies & Market Share Insights

Key companies are undertaking extensive strategic initiatives in the field of immunoassays, including mergers and acquisitions, new product development, and regional expansion, to address the unmet needs of patients. In November 2020, Siemens Healthineers announced that its SARS-CoV-2 IgG Antibody Test has proven to measure neutralizing antibodies and has gained CE Marking. This test is an improved version of its previously launched COVID-19 antibody test. In November 2018, bioMérieux acquired a majority stake in Suzhou Hybiome Biomedical Engineering Co. Ltd. This acquisition is expected to strengthen the company’s presence in the market in China. Some of the prominent players in the immunoassay market include:

• Siemens Healthineers

• bioMérieux SA

• Abbott Laboratories

• Danaher Corporation (Beckman Coulter)

• Quidel Corporation

• Ortho Clinical Diagnostics

• Sysmex Corporation

• Bio-Rad Laboratories, Inc.

• Becton, Dickinson, and Company

• F. Hoffmann-La Roche AG

• Thermo Fisher Scientific, Inc.

Immunoassay Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest trends and opportunities in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global immunoassay market report on the basis of product, technology, application, end use, and region:

• Product Outlook (Revenue, USD Million, 2016 - 2028)

  • Reagents & Kits

  • Analyzers/Instruments

    • Open Ended Systems

    • Closed Ended Systems

  • Software & Services

• Technology Outlook (Revenue, USD Million, 2016 - 2028)

  • Radioimmunoassay (RIA)

  • Enzyme Immunoassays (EIA)

    • Chemiluminescence Immunoassays (CLIA)

    • Fluorescence Immunoassays (FIA)

  • Rapid Test

  • Others

• Application Outlook (Revenue, USD Million, 2016 - 2028)

  • Therapeutic Drug Monitoring

  • Oncology

  • Cardiology

  • Endocrinology

  • Infectious Disease Testing

  • Autoimmune Diseases

  • Others

• End-use Outlook (Revenue, USD Million, 2016 - 2028)

  • Hospitals

  • Blood Banks

  • Clinical Laboratories

  • Pharmaceutical and Biotech Companies

  • Academic Research Centers

  • Others

• Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Singapore

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE